FDA.report

Fapon

Primary DI
06977159190002
Brand
Fapon
Company
Guangdong Fapon Biotech Co. Ltd.,
Model
/
Published
2024-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PPMGeneral Purpose Reagent

Product Code Classifications

CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06977159190002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06977159190002069771591900026977159190002

GMDN Terms

TermDefinition
Specimen stabilization reagent IVDA substance or reactant intended to be used alone or in combination with other IVDs to prevent degradation of sensitive analytes (e.g., hormones, proteins, peptides and/or nucleic acids) in a clinical specimen during transportation, storage or processing. A stabilizer is typically a solvent, antioxidant or an enzyme inhibitor.

Sterilization Methods

Method

Regulatory Flags

DUNS number
544570177
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

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08033891322595CHORUS NEGATIVE CONTROL/SAMPLE DILUENTDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322816CHORUS EVO DECONTAMINATION BUFFERDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322823CHORUS EVO SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891328849CHORUS SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
00847627043726NeoPath Background Punisher BIOCARE MEDICAL LLCPPM2026-03-11
04049016151302FITC-labelled anti-human IgA with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
00630414312460Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414312507Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
05407010129847Buffer C_SUO-001_Module L : 1000L BagLonza VerviersPPM2026-02-05
05407010129854Buffer C_SUO-001_Module L : 1L Bag SampLonza VerviersPPM2026-02-05
00847627043023NeoPATH Pro Rabbit Amp AP Plus KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043047NeoPATH Pro Universal AP Plus Polymer KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043061NeoPATH Pro Antigen Retrieval 1 (AR1)BIOCARE MEDICAL LLCPPM2026-01-29
04049016151340FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
04049016151654FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
05430003908471SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908693SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908631SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908709SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908730LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908785LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908808LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908846LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908860LaCAR Lacar MDX TechnologiesPPM2026-01-15
08435804522199FISH PT KITVITRO SAPPM2026-01-15
08435804522212DEWAX-2 FISHVITRO SAPPM2026-01-15
08435804522366FISH PT KITVITRO SAPPM2026-01-15
08435804522397DEWAX-2 FISH VITRO SAPPM2026-01-15